Diabetes Mellitus, Type 1Phase 2NCT00883558

Safety Study of Subcutaneously-Injected Prandial INSULIN-PH20 NP Compared to Insulin Lispro Injection in Participants With Type 1 Diabetes Mellitus

A Phase 2 study testing Insulin Lispro, regular human insulin and recombinant human hyaluronidase PH20 in people with Diabetes Mellitus, Type 1, run by Halozyme Therapeutics at 8 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 65 years
Conditions the study is for: Diabetes Mellitus, Type 1
What is being tested?: Insulin Lispro, regular human insulin and recombinant human hyaluronidase PH20
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 48 participants
Where: 8 sitesUnited States
Study dates: May 2009to Apr 2010
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 65 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Male or female of age 18 to 65 years, inclusive. Females of child-bearing potential must use a standard and effective means of birth control for the duration of the study.
Participants with Type 1 diabetes mellitus (T1DM) (per World Health Organization [WHO] criteria) treated with insulin for ≥24 months.
Participants who use an insulin infusion pump for basal insulin administration must be on the device for at least 90 days prior to screening.
Body mass index (BMI) 18.0 to 35.0 kilograms per square meter (kg/m^2), inclusive.
Glycosylated hemoglobin A1c (HbA1c) ≤7.5 % based on central laboratory screening results.
Fasting C-peptide <0.6 nanograms per milliliter (ng/mL).
Participants should be in good general health based on medical history and physical examination and without medical conditions that might prevent the completion of study drug injections and assessments required in this protocol.

Who cannot join

Known or suspected allergy to any component of any of the study drugs in this study.
Previous enrollment in this study. Participants who fail Screening may attempt to rescreen into the study.
A participant who has proliferative retinopathy or maculopathy, and/or severe neuropathy, in particular autonomic neuropathy, as judged by the Investigator.
As judged by the Investigator, clinically significant active disease of the gastrointestinal, cardiovascular (including a history of arrhythmia or conduction delays on electrocardiogram [ECG]), hepatic, neurological, renal, genitourinary, or hematological systems.
As judged by the Investigator, uncontrolled hypertension (diastolic blood pressure ≥100 millimeters of mercury [mmHg] and/or systolic blood pressure ≥160 mmHg after 5 minutes in the supine position). Three attempts may be performed to measure blood pressure.
History of any illness or disease that in the opinion of the Investigator might confound the results of the study or pose additional risk in administering the study drugs to the participant.

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As judged by the Investigator, clinically significant findings in routine laboratory data.
Use of drugs (such as systemic corticosteroids) that may interfere with the interpretation of study results or are known to cause clinically relevant interference with insulin action, glucose utilization, or recovery from hypoglycemia.
Recurrent severe hypoglycemia (more than 2 episodes over the last 6 months) or hypoglycemic unawareness, as judged by the Investigator.
Current addiction to alcohol or substances of abuse, as determined by the Investigator.
Pregnancy, breast-feeding, the intention of becoming pregnant, or not using adequate contraceptive measures (adequate contraceptive measures consist of sterilization, intra-uterine device [IUD], oral or injectable contraceptives, or barrier methods).
Mental incapacity, unwillingness, or language barriers precluding adequate understanding or cooperation in this study.
Receipt of any investigational drug within 4 weeks of Screening.
Any condition (intrinsic or extrinsic) that in the judgment of the Investigator will interfere with study participation or evaluation of data. Examples would include: renal insufficiency (serum creatinine >1.5 milligrams per deciliter [mg/dL] for males or >1.4 mg/dL for females), congestive heart failure required medication treatment, and cardiac disease with New York Heart Association (NYHA) Functional Capacity of III/IV.

Trial locations and contacts

8 sites in 1 country.

City, postcode or hospital

8 sites in 1 country

United States8 sites

Barbara Davis Center for Childhood Diabetes
Aurora, Colorado, 80045
Texas Diabetes and Endocrinology
Austin, Texas, 78731
Mercury Street Medical
Butte, Montana, 59701
Cleveland Clinic
Cleveland, Ohio, 44195
Henry Ford Health System
Detroit, Michigan, 48202
UNC Diabetes Care Center/Highgate Specialty Center
Durham, North Carolina, 27713
Diabetes Research Institute
Miami, Florida, 33136
West Olympia Internal Medicine
Olympia, Washington, 98502

Other trials in United States

About this study

Official title: A Phase II, Randomized, Open Label, 2-Way Crossover, Safety Study of Subcutaneously Injected Prandial INSULIN-PH20 NP Compared to Insulin Analog Injection in Patients With Type 1 Diabetes

Insulin lispro is approved by the Food and Drug Administration (FDA) for the treatment of diabetes mellitus. Recombinant human hyaluronidase (rHuPH20) is approved by the FDA as an aid to the absorption and dispersion of other injectable drugs. In this study, rHuPH20 combined with a non-preserved (NP) formulation of regular human insulin (INSULIN-PH20 NP) will be compared to insulin lispro with respect to absorption and action of insulin.

Read the detailed description

The purpose of this study is to compare the safety and tolerability of INSULIN-PH20 NP versus insulin lispro alone.

Conditions: Diabetes Mellitus, Type 1
Being tested: Insulin Lispro, regular human insulin, recombinant human hyaluronidase PH20, Insulin glargine
Keywords: recombinant human hyaluronidase (rHuPH20), Insulin lispro, regular human insulin
Medical subject headings: Diabetes Mellitus, Type 1, Insulin Resistance

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Insulin LisproDrug
Also called Humalog
regular human insulinDrug
Also called Humulin R
recombinant human hyaluronidase PH20Drug
Also called Hylenex, rHuPH20, PH20
Insulin glargineDrug
Also called Lantus

Study groups in NCT00883558
Study group	Role	What they receive
INSULIN-PH20 NP / Insulin Lispro	Experimental	All enrolled participants underwent a 1-month dose titration period and received 100 units per milliliter (U/mL) insulin lispro, injected subcutaneously (SC) pre-meals, with doses titrated to each participant individually. Next participants were randomly assigned to 1 of 2 study treatments (Treatment A or B) for the first of two, 3-month treatment cycles. Each participant then received the second treatment for the second cycle. INSULIN-PH20 NP (Treatment A): 100 U/mL non-preserved (NP) formulation of regular human insulin with 5.0 micrograms per milliliter (µg/mL) recombinant human hyaluronidase PH20, injected SC, pre-meals, doses titrated to each participant individually. Insulin Lispro (Treatment B): 100 U/mL insulin lispro, injected SC, pre-meals, doses titrated to each participant individually. Throughout the study, participants requiring basal insulin used twice daily SC injections of 100 U/mL insulin glargine or maintained their usual regimen through an insulin pump. Receives: Drug: Insulin Lispro; Drug: regular human insulin; Drug: recombinant human hyaluronidase PH20; Drug: Insulin glargine

What is being measured

The primary outcome is the main question the study is designed to answer.

Postprandial Glucose Excursion
A 2-hour postprandial glucose excursion was measured for 3 meals over 3 days during each treatment cycle (3 days during Week 14 of the first treatment cycle and 3 days during Week 26 of the second treatment cycle). For each of the 3 days, the mealtime (breakfast, lunch, and dinner) excursions were calculated as the post-meal glucose value minus the pre-meal value as determined by 8-point glucose monitoring. The average of all excursions over the 3 days for the corresponding treatment cycle is presented.
Measured: Week 14 and Week 26

Secondary outcomes (2)

Time Spent With Blood Glucose Value Outside a 71-139 Milligrams Per Deciliter (mg/dL) Range During Continuous Glucose Monitoring
Participants were provided a continuous glucose monitoring (CGM) device, consisting of a sensor, transmitter, and receiver. Total time the participant's blood glucose was outside the 71-139 mg/dL range during 3 days of CGM during each treatment cycle (3 days during Week 14 of the first treatment cycle and 3 days during Week 26 of the second treatment cycle) is presented.
Measured: Week 14 and Week 26
Number of Participants With Hypoglycemic Events
The number of participants with at least one hypoglycemic event (HE) reported during the entire study is presented. Additionally, the number of participants with severe HEs (those that necessitated administration of carbohydrate or glucagon, or resuscitation, by another person) is also presented. A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.
Measured: Baseline through Week 29

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

May 2009Apr 2010

First posted17 Apr 2009 (estimated)
Study startMay 2009
Primary completionFeb 2010
Study completionApr 2010

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Diabetes Mellitus, Type 1Studies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Enrolment: 48 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00883558
Sponsor's protocol ID: HALO-117-203
Status last verified: Aug 2014
First submitted: 15 Apr 2009
Last updated: 8 Sep 2014
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 8 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase II, Randomized, Open Label, 2-Way Crossover, Safety Study of Subcutaneously Injected Prandial INSULIN-PH20 NP Compared to Insulin Analog Injection in Patients With Type 1 Diabetes
ClinicalTrials.gov ID: NCT00883558
Acronym / sponsor ID: HALO-117-203
Conditions: Diabetes Mellitus, Type 1
Keywords: recombinant human hyaluronidase (rHuPH20), Insulin lispro, regular human insulin
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 48 participants (actual)
Lead sponsor: Halozyme TherapeuticsIndustry (pharma, biotech, devices)
Study start: May 2009
Primary completion: Feb 2010 (actual)
Study completion: Apr 2010 (actual)
First posted: 17 Apr 2009 (estimated)
Results: Posted 8 Sep 2014

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

The purpose of this study is to compare the safety and tolerability of INSULIN-PH20 NP versus insulin lispro alone.

Study design

Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
INSULIN-PH20 NP / Insulin Lispro	Experimental	Drug: Insulin Lispro, Drug: regular human insulin, Drug: recombinant human hyaluronidase PH20, Drug: Insulin glargineAll enrolled participants underwent a 1-month dose titration period and received 100 units per milliliter (U/mL) insulin lispro, injected subcutaneously (SC) pre-meals, with doses titrated to each participant individually. Next participants were randomly assigned to 1 of 2 study treatments (Treatment A or B) for the first of two, 3-month treatment cycles. Each participant then received the second treatment for the second cycle. INSULIN-PH20 NP (Treatment A): 100 U/mL non-preserved (NP) formulation of regular human insulin with 5.0 micrograms per milliliter (µg/mL) recombinant human hyaluronidase PH20, injected SC, pre-meals, doses titrated to each participant individually. Insulin Lispro (Treatment B): 100 U/mL insulin lispro, injected SC, pre-meals, doses titrated to each participant individually. Throughout the study, participants requiring basal insulin used twice daily SC injections of 100 U/mL insulin glargine or maintained their usual regimen through an insulin pump.

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (7 listed)

Male or female of age 18 to 65 years, inclusive. Females of child-bearing potential must use a standard and effective means of birth control for the duration of the study.
Participants with Type 1 diabetes mellitus (T1DM) (per World Health Organization [WHO] criteria) treated with insulin for ≥24 months.
Participants who use an insulin infusion pump for basal insulin administration must be on the device for at least 90 days prior to screening.
Body mass index (BMI) 18.0 to 35.0 kilograms per square meter (kg/m^2), inclusive.
Glycosylated hemoglobin A1c (HbA1c) ≤7.5 % based on central laboratory screening results.

Key exclusion criteria (14 listed)

Known or suspected allergy to any component of any of the study drugs in this study.
Previous enrollment in this study. Participants who fail Screening may attempt to rescreen into the study.
A participant who has proliferative retinopathy or maculopathy, and/or severe neuropathy, in particular autonomic neuropathy, as judged by the Investigator.
As judged by the Investigator, clinically significant active disease of the gastrointestinal, cardiovascular (including a history of arrhythmia or conduction delays on electrocardiogram [ECG]), hepatic, neurological, renal, genitourinary, or hematological systems.
As judged by the Investigator, uncontrolled hypertension (diastolic blood pressure ≥100 millimeters of mercury [mmHg] and/or systolic blood pressure ≥160 mmHg after 5 minutes in the supine position). Three attempts may be performed to measure blood pressure.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Insulin LisproAlso: Humalog	Drug	INSULIN-PH20 NP / Insulin Lispro
regular human insulinAlso: Humulin R	Drug	INSULIN-PH20 NP / Insulin Lispro
recombinant human hyaluronidase PH20Also: Hylenex, rHuPH20, PH20	Drug	INSULIN-PH20 NP / Insulin Lispro
Insulin glargineAlso: Lantus	Drug	INSULIN-PH20 NP / Insulin Lispro

Primary outcome

Postprandial Glucose Excursion
Time frame: Week 14 and Week 26
A 2-hour postprandial glucose excursion was measured for 3 meals over 3 days during each treatment cycle (3 days during Week 14 of the first treatment cycle and 3 days during Week 26 of the second treatment cycle). For each of the 3 days, the mealtime (breakfast, lunch, and dinner) excursions were calculated as the post-meal glucose value minus the pre-meal value as determined by 8-point glucose monitoring. The average of all excursions over the 3 days for the corresponding treatment cycle is presented.

2 secondary outcomes

Time Spent With Blood Glucose Value Outside a 71-139 Milligrams Per Deciliter (mg/dL) Range During Continuous Glucose Monitoring
Time frame: Week 14 and Week 26
Number of Participants With Hypoglycemic Events
Time frame: Baseline through Week 29

Results and safety

Results posted to the registry on 8 Sep 2014, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
All Enrolled Participants	48	46
INSULIN-PH20 NP First, Then Insulin Lispro	0	0
Insulin Lispro First, Then INSULIN-PH20 NP	0	0

Primary outcome: Postprandial Glucose Excursion

Time frame: Week 14 and Week 26. Mean (Standard Deviation). Unit: milligrams per deciliter (mg/dL)

Measure	INSULIN-PH20 NP n = 37	Insulin Lispro n = 37
Value	17.23 (36.040)	14.47 (35.113)

INSULIN-PH20 NP vs Insulin Lispro: LS Mean Difference: 3.06, p = 0.3217, Mixed Models Analysis

Population analysed: Participants who completed both treatment cycles with evaluable postprandial glucose data.

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: An adverse event was considered treatment-emergent if the start date of the event was on or after the date of randomization.. Other adverse events reported at 3% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
INSULIN-PH20 NP Treatment Period	2 of 45 (4.4%)	17 of 45 (37.8%)	Not reported
Insulin Lispro Treatment Period	1 of 43 (2.3%)	11 of 43 (25.6%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2014.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Douglas Muchmore, M.D. study director

Halozyme Therapeutics

8 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Sep 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 8 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 8 Sep 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Postprandial Glucose Excursion (time frame: Week 14 and Week 26). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00883558.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Sep 2014.